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Study of CS-3150 in Patients With Essential Hypertension (ESAX-HTN)

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
CS-3150
Eplerenone
Sponsored by
Daiichi Sankyo Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Essential hypertension, Mineralocorticoid receptor antagonist, Esaxerenone, Ambulatory blood pressure monitoring

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female subjects aged 20 years or older at informed consent

  • Subjects with essential hypertension satisfying the following blood pressure criteria;

    • Sitting SBP: ≥ 140 mmHg and < 180 mmHg
    • Sitting DBP: ≥ 90 mmHg and < 110 mmHg
    • Mean 24 hr BP: SBP ≥ 130 and DBP ≥ 80 mmHg

Exclusion Criteria:

  • Secondary hypertension or malignant hypertension
  • Diabetic nephropathy or diabetes mellitus with albuminuria
  • Serum potassium level < 3.5 or ≥ 5.1 mEq/L
  • Reversed day-night life cycle including overnight workers
  • eGFR < 60 mL/min/1.73 m^2

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

CS-3150 2.5 mg

CS-3150 5.0 mg

Eplerenone

Arm Description

CS-3150 2.5 mg, orally, once daily after breakfast for 12 weeks

CS-3150 5 mg, orally, once daily after breakfast for 12 weeks

Eplerenone 50 mg, orally, once daily after breakfast for 12 weeks

Outcomes

Primary Outcome Measures

Change from baseline in sitting blood pressure
Change from baseline in sitting systolic (SBP) and diastolic blood pressure (DBP).

Secondary Outcome Measures

Change from baseline in 24 hour average blood pressure
Change from baseline in 24 hour average systolic and diastolic blood pressure.

Full Information

First Posted
August 29, 2016
Last Updated
December 19, 2018
Sponsor
Daiichi Sankyo Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02890173
Brief Title
Study of CS-3150 in Patients With Essential Hypertension
Acronym
ESAX-HTN
Official Title
A Double Blind Study of CS-3150 to Evaluate Efficacy and Safety Compared to Eplerenone in Patients With Essential Hypertension (ESAX-HTN Study)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
July 11, 2017 (Actual)
Study Completion Date
July 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate antihypertensive effect and safety of CS-3150 compared to Eplerenone in patients with essential hypertension.
Detailed Description
Primary objective is to evaluate antihypertensive effect and safety of CS-3150 2.5 mg compared to Eplerenone in patients with essential hypertension. Secondary objective is to evaluate antihypertensive effect and safety of CS-3150 5.0 mg compared to 2.5 mg.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Essential hypertension, Mineralocorticoid receptor antagonist, Esaxerenone, Ambulatory blood pressure monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1001 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CS-3150 2.5 mg
Arm Type
Experimental
Arm Description
CS-3150 2.5 mg, orally, once daily after breakfast for 12 weeks
Arm Title
CS-3150 5.0 mg
Arm Type
Experimental
Arm Description
CS-3150 5 mg, orally, once daily after breakfast for 12 weeks
Arm Title
Eplerenone
Arm Type
Active Comparator
Arm Description
Eplerenone 50 mg, orally, once daily after breakfast for 12 weeks
Intervention Type
Drug
Intervention Name(s)
CS-3150
Intervention Type
Drug
Intervention Name(s)
Eplerenone
Other Intervention Name(s)
Inspra
Primary Outcome Measure Information:
Title
Change from baseline in sitting blood pressure
Description
Change from baseline in sitting systolic (SBP) and diastolic blood pressure (DBP).
Time Frame
Baseline to end of Week 12
Secondary Outcome Measure Information:
Title
Change from baseline in 24 hour average blood pressure
Description
Change from baseline in 24 hour average systolic and diastolic blood pressure.
Time Frame
Baseline to end of Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female subjects aged 20 years or older at informed consent Subjects with essential hypertension satisfying the following blood pressure criteria; Sitting SBP: ≥ 140 mmHg and < 180 mmHg Sitting DBP: ≥ 90 mmHg and < 110 mmHg Mean 24 hr BP: SBP ≥ 130 and DBP ≥ 80 mmHg Exclusion Criteria: Secondary hypertension or malignant hypertension Diabetic nephropathy or diabetes mellitus with albuminuria Serum potassium level < 3.5 or ≥ 5.1 mEq/L Reversed day-night life cycle including overnight workers eGFR < 60 mL/min/1.73 m^2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Daiichi Sankyo Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Sapporo
State/Province
Hokkaido
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD Sharing Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD Sharing Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/
Citations:
PubMed Identifier
31786983
Citation
Ito S, Itoh H, Rakugi H, Okuda Y, Yoshimura M, Yamakawa S. Double-Blind Randomized Phase 3 Study Comparing Esaxerenone (CS-3150) and Eplerenone in Patients With Essential Hypertension (ESAX-HTN Study). Hypertension. 2020 Jan;75(1):51-58. doi: 10.1161/HYPERTENSIONAHA.119.13569. Epub 2019 Dec 2.
Results Reference
derived

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Study of CS-3150 in Patients With Essential Hypertension

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